Mechanical Valve ReplacementPhase 4NCT00298285
ABRIDGE: Low Molecular Weight Heparin in Bridging Patients After Mechanical Valve Replacement
A Phase 4 study testing enoxaparin in people with Mechanical Valve Replacement and Warfarin Therapy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The primary aim is to determine the rate of major bleeding and blood clots when using enoxaparin as a bridge to oral blood thinning medication in patients who have undergone mechanical valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Valve Replacement, Warfarin Therapy
- What is being tested?
- enoxaparin
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting all the following will be considered for enrollment.
- Male or non-pregnant female (negative pregnancy test is required for women of child bearing potential) ≥ 18 of age who are able to provide informed consent and able to self-administer enoxaparin.
- Body weight ≥ 45kg and ≤ 150kg.
- Patients who are post prosthetic mechanical valve surgery and will need oral anticoagulation after discharge from the hospital.
- One who has undergone valve replacement with mechanical prosthesis in the mitral position.
- One who has undergone valve replacement with mechanical prosthesis in the aortic position.
- One who has undergone valve replacement with mechanical prosthesis in the tricuspid position.
Who cannot join
- Patients with any of the following will not be eligible for enrollment in the study:
- Contraindication or sensitivity to unfractionated heparin/ low molecular weight heparin: history of heparin associated thrombocytopenia, heparin induced thrombocytopenia, or heparin induced thrombotic thrombocytopenia syndrome;
- History of, or current, cardiogenic shock;
- Active endocarditis (requiring > 4 weeks of antibiotics);
- Active bleeding or bleeding diathesis;
- History of gastrointestinal bleeding and /or endoscopically verified ulcer disease within the last three months;
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- Known proliferative diabetic retinopathy or history of intraocular bleeding;
- Ischemic stroke in the previous three months or any hemorrhagic stroke, known brain tumor, intracranial aneurysm or intracranial AV malformation;
- Renal insufficiency (cr clearance < 30 cc/min), cr clearance calculation:
- Women = 0.85 x (140 - age) x body weight (kg) / 72 x serum creat (mg/dl), Men = (140 - age) x body weight (kg) / 72 x serum creat (mg/dl), or patient with a renal transplant;
- Anemia (Hgb < 8 gm/dl);
- Thrombocytopenia (platelet count < 100 x 109/L);
- Liver disease demonstrated by ALT > 144u/L
- Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg);
- Life expectancy less than 6 months;
- Moderate pericardial effusion as diagnosed by echo;
- Concomitant use of clopidogrel, or cyclooxygenase 1 or 2 inhibitors or use within seven days;
- Non- medical exclusion
- Patients unable or unwilling to provide consent.
- Patients unable or unwilling to have follow-up echocardiogram.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ABRIDGE: Low Molecular Weight Heparin in Bridging Patients After Mechanical Valve Replacement. A Pilot Study
The primary aim is to determine the rate of major bleeding and blood clots when using enoxaparin as a bridge to oral blood thinning medication in patients who have undergone mechanical valve replacement.
Read the detailed description
Patients who undergo mechanical heart valve replacement are usually placed on long-term oral anticoagulation (blood thinning) medication to prevent blood clots from forming on the mechanical valve. This is started in the hospital with intravenous unfractionated heparin; patients must remain in the hospital while on unfractionated heparin. At the same time, an oral blood thinner is started (warfarin). This process is commonly referred to as "bridging." Once the warfarin reaches the proper level, the intravenous heparin is stopped.
This is a single center, non-randomized pilot study using twice a day enoxaparin injections in place of unfractionated heparin as a bridge to warfarin therapy. A total of approximately 100 patients will be enrolled. Patients will be instructed how to give the enoxaparin injections at home. Blood will be drawn every 1-2 days to monitor warfarin levels. Once discharged, patients will continue to have their blood level checked until warfarin is at the correct level, at which point enoxaparin will be discontinued. All patients who develop signs or symptoms of a stroke or abnormal blood clotting will be asked to return for an echocardiogram. An echocardiogram and 12-lead ECG will be done at approximately 30 days after the start of the study.
Additionally the first 100 consecutive patients who fit the inclusion criteria but do not consent to the enoxaparin strategy will be asked to enter a registry that will monitor their hospital stay and information from their routine 30 day follow-up visit will be collected.
- Conditions
- Mechanical Valve Replacement, Warfarin Therapy
- Being tested
- enoxaparin
- Keywords
- mechanical valve replacement, warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enoxaparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial thromboembolism
major bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Valve ReplacementStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Allan Klein, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298285
- Sponsor's protocol ID
- ABRIDGE
- Status last verified
- Jan 2006
- First submitted
- 28 Feb 2006
- Last updated
- 9 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABRIDGE: Low Molecular Weight Heparin in Bridging Patients After Mechanical Valve Replacement. A Pilot Study
- ClinicalTrials.gov ID
- NCT00298285
- Acronym / sponsor ID
- ABRIDGE
- Conditions
- Mechanical Valve Replacement, Warfarin Therapy
- Keywords
- mechanical valve replacement, warfarin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study completion
- Oct 2006
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to determine the rate of major bleeding and blood clots when using enoxaparin as a bridge to oral blood thinning medication in patients who have undergone mechanical valve replacement.
Detailed description
Patients who undergo mechanical heart valve replacement are usually placed on long-term oral anticoagulation (blood thinning) medication to prevent blood clots from forming on the mechanical valve. This is started in the hospital with intravenous unfractionated heparin; patients must remain in the hospital while on unfractionated heparin. At the same time, an oral blood thinner is started (warfarin). This process is commonly referred to as "bridging." Once the warfarin reaches the proper level, the intravenous heparin is stopped.
This is a single center, non-randomized pilot study using twice a day enoxaparin injections in place of unfractionated heparin as a bridge to warfarin therapy. A total of approximately 100 patients will be enrolled. Patients will be instructed how to give the enoxaparin injections at home. Blood will be drawn every 1-2 days to monitor warfarin levels. Once discharged, patients will continue to have their blood level checked until warfarin is at the correct level, at which point enoxaparin will be discontinued. All patients who develop signs or symptoms of a stroke or abnormal blood clotting will be asked to return for an echocardiogram. An echocardiogram and 12-lead ECG will be done at approximately 30 days after the start of the study.
Additionally the first 100 consecutive patients who fit the inclusion criteria but do not consent to the enoxaparin strategy will be asked to enter a registry that will monitor their hospital stay and information from their routine 30 day follow-up visit will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients meeting all the following will be considered for enrollment.
- Male or non-pregnant female (negative pregnancy test is required for women of child bearing potential) ≥ 18 of age who are able to provide informed consent and able to self-administer enoxaparin.
- Body weight ≥ 45kg and ≤ 150kg.
- Patients who are post prosthetic mechanical valve surgery and will need oral anticoagulation after discharge from the hospital.
Key exclusion criteria (20 listed)
- Contraindication or sensitivity to unfractionated heparin/ low molecular weight heparin: history of heparin associated thrombocytopenia, heparin induced thrombocytopenia, or heparin induced thrombotic thrombocytopenia syndrome;
- History of, or current, cardiogenic shock;
- Active endocarditis (requiring > 4 weeks of antibiotics);
- Active bleeding or bleeding diathesis;
- History of gastrointestinal bleeding and /or endoscopically verified ulcer disease within the last three months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enoxaparin | Drug | – |
Primary outcome
arterial thromboembolism
major bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2007.
Related trials for Mechanical Valve Replacement
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RecruitingPhase 4
Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
AORTIC VALVE DISEASES, Thromboembolism
Active, not recruitingObservational study
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Klein, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing enoxaparin in people with Mechanical Valve Replacement and Warfarin Therapy, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial thromboembolism. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2007.